Fluticasone + Salmeterol

Introduction: Fluticasone + Salmeterol is a combination inhaler used in the regular treatment of asthma and COPD. Salmeterol Xinafoate is a selective long-acting beta-2 agonist and Fluticasone Propionate is a corticosteroid with mainly glucocorticoid activity.

How it works: Salmeterol protects against symptoms and Fluticasone improves lung function and prevents exacerbations.

Important Information: This inhaler is not for the primary treatment of acute asthma attacks. Patients should always have a fast-acting bronchodilator (e.g., salbutamol) available.

• Asthma: where use of a combination product is appropriate - patients not adequately controlled with inhaled corticosteroids and 'as needed' short-acting β₂-agonist, or patients already adequately controlled on both.
• COPD: Regular treatment of chronic obstructive pulmonary disease.

Long-acting selective β-adrenoceptor stimulants, Respiratory corticosteroids

Long-acting β₂-agonist + Inhaled corticosteroid

Salmeterol Xinafoate is a selective long-acting (12-hour) beta-2-adrenoceptor agonist with a long side chain that binds to the exo-site of the receptor. Fluticasone Propionate given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbations of asthma.

Salmeterol relaxes bronchial smooth muscles to improve airflow. Fluticasone reduces lung inflammation by decreasing inflammatory cell activity.

Inhaler (Adults and 12+ years):

• 2 puffs of 25 µg + 50 µg twice daily
• 2 puffs of 25 µg + 125 µg twice daily
• 2 puffs of 25 µg + 250 µg twice daily

Children (4-12 years):

• 2 puffs of 25 µg + 50 µg twice daily

Inhalation Capsule (Asthma):

• 50 µg + 100 µg or 50 µg + 250 µg twice daily

Inhalation Capsule (COPD):

• 50 µg + 250 µg twice daily

* Use as directed by the registered physician

Instructions for using the inhaler:

• Remove the cap.
• Shake the inhaler vigorously (at least 6 times).
• Breathe out fully.
• Place mouthpiece in mouth and close lips around it.
• While breathing in deeply and slowly, press down firmly on the canister to release the medicine.
• Hold breath for 10 seconds.
• Rinse mouth with water after each use.

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and follow your regular schedule.

Salmeterol-related side effects:

• Tremor
• Palpitations
• Headache
• Cardiac arrhythmia
• Muscle cramps

Fluticasone-related side effects:

• Hoarseness
• Candidiasis of mouth and throat
• Hypersensitivity reactions

Precautions:

• Do not use in acute asthma attacks (fast-acting bronchodilator needed).
• Seek medical advice if asthma symptoms remain uncontrolled or worsen.
• Paradoxical bronchospasm may occur - use bronchodilator immediately and discontinue.
• COPD patients: increased reporting of pneumonia - remain vigilant.
• Systemic effects (Cushing's syndrome, adrenal suppression, growth retardation) may occur with high doses long-term.

Contraindications:

• Hypersensitivity to salmeterol xinafoate, fluticasone propionate or excipients
• Primary treatment of status asthmaticus or other acute asthma episodes

Drug Interactions:

• Avoid non-selective and selective β-blockers.
• Caution with strong CYP3A4 inhibitors (ketoconazole, ritonavir).

Food Interactions: No interaction found/established.

Use in Pregnancy: Use during pregnancy only if the expected benefit to the mother is greater than any possible risk to the fetus or child.

Use in Lactation: Use during breastfeeding only if the expected benefit to the mother is greater than any possible risk to the child.

Pediatric Use: Specific dosage available for children 4-12 years. No data available for children under 4 years.

Geriatric Use: No dose adjustment needed for elderly patients.

Renal Impairment: No dose adjustment needed.

Hepatic Impairment: No data available for use in patients with hepatic impairment.

Overdose:

• Salmeterol: Seizures, angina, hypertension/hypotension, tachycardia, arrhythmias, hypokalemia, hyperglycemia.
• Fluticasone: Temporary suppression of adrenal function.

Storage: Pressurised canister - do not puncture, break or incinerate. Avoid direct sunlight or heat. Store below 30°C.

Fluticasone + Salmeterol Inhaler